Mei Pharma Initiates Phase II Clinical Trial Of Pracinostat And Vidaza® In
Frontline Myelodysplastic Syndrome
First Patients Dosed in Multicenter, Randomized, Placebo-Controlled Study
PR Newswire
SAN DIEGO, June 18, 2013
SAN DIEGO, June 18, 2013 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), an
oncology company focused on the clinical development of novel therapies for
cancer, announced today that the first patients have been dosed in a Phase II
clinical trial of its lead drug candidate Pracinostat in combination with
Vidaza (azacitidine) in patients with previously untreated intermediate-2 or
high-risk myelodysplastic syndrome (MDS). The randomized, double-blind trial
is designed to evaluate the safety and efficacy of Pracinostat compared to
placebo when combined with Vidaza, a drug approved by the U.S. Food & Drug
Administration (FDA) for the treatment of MDS.
(Logo:http://photos.prnewswire.com/prnh/20120628/LA32362LOGO)
Results from an earlier pilot study of Pracinostat in combination with Vidaza
in patients with intermediate-2 or high-risk MDS presented at the American
Society of Hematology (ASH) Annual Meeting in December 2012 showed an overall
response rate of 89% (eight out of nine), including seven patients who
achieved either a complete remission (CR) or a complete remission with
incomplete blood count recovery (CRi).
"The initiation of this randomized Phase II trial is an important milestone in
the clinical development of Pracinostat," said Robert D. Mass, MD, Chief
Medical Officer of MEI Pharma. "The results from the pilot study reported at
ASH were very exciting and helped to inform the design of this more robust,
placebo-controlled trial. Now, our goal is to build on these preliminary data
and get a more precise estimate of the clinical benefit of Pracinostat in
combination with standard-of-care."
The multicenter Phase II trial is expected to enroll 100 patients with a
one-to-one randomization. Completion of enrollment is anticipated by June 2014
with topline data in December 2014. The primary endpoint of the study is
complete remission (CR). Secondary endpoints include overall response rate
(CR+CRi+PR), hematologic improvement, duration of response, progression-free
survival, rate of leukemic transformation, overall survival and safety. The
trial is being conducted in collaboration with the Sarah Cannon Research
Institute; Dr. Guillermo Garcia-Manero of the MD Anderson Cancer Center is the
principal investigator. Additional information regarding the trial is
available at www.clinicaltrials.gov.
"This represents the first in a series of Phase II studies we have planned for
Pracinostat in the months ahead," said Daniel P. Gold, Ph.D., President and
Chief Executive Officer of MEI Pharma. "We believe that Pracinostat truly has
the potential to become a best-in-class drug. We intend to execute a
comprehensive development program in order to realize its full potential and
determine the most efficient registration path forward."
In addition to the randomized Phase II clinical trial in frontline MDS, the
Company is also preparing for the initiation of two open-label Phase II trials
of Pracinostat: one in combination with Vidaza in frontline acute myeloid
leukemia (AML) in the fall of 2013 and the other in combination with Vidaza or
Dacogen^® (decitabine) in patients with refractory MDS soon thereafter.
About Pracinostat
Pracinostat is an orally available histone deacetylase (HDAC) inhibitor that
has been tested in a number of Phase I and exploratory Phase II clinical
trials in advanced hematologic disorders and solid tumor indications in both
adult and pediatric patients. Pracinostat has been generally well tolerated in
more than 200 patients to date, with readily manageable side effects that are
often associated with drugs of this class, such as fatigue. Pracinostat has
exhibited pharmacokinetic properties that compare favorably to other oral HDAC
inhibitors, including Zolinza^® (vorinostat), which is approved by the FDA for
the treatment of cutaneous T-cell lymphoma. In addition to the evidence of
clinical activity observed in combination with Vidaza in patients with MDS,
Pracinostat has demonstrated single-agent activity in AML, including two CRs
out of 14 patients (14%) in a dose-escalation trial, with durable responses
persisting up to 362 days.
MEI Pharma owns exclusive worldwide rights to Pracinostat.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused
on the clinical development of novel therapies for cancer. The Company's lead
drug candidate is Pracinostat, a potential best-in-class, oral HDAC inhibitor
being developed for advanced hematologic malignancies, such as MDS and AML.
Results from a pilot Phase II clinical trial of Pracinostat in combination
with Vidaza in patients with MDS presented at the American Society of
Hematology Annual Meeting in December 2012 showed an overall response rate of
89% (eight out of nine). The Company initiated a randomized,
placebo-controlled Phase II trial of Pracinostat in combination with Vidaza in
patients with previously untreated MDS in June 2013. In addition, MEI Pharma
is developing two drug candidates derived from its isoflavone-based technology
platform, ME-143 and ME-344. For more information, go to www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated
in clinical trials and approved by the FDA as being safe and effective for the
intended use. Statements included in this press release that are not
historical in nature are "forward-looking statements" within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995. You should be aware that our actual results could differ materially
from those contained in the forward-looking statements, which are based on
management's current expectations and are subject to a number of risks and
uncertainties, including, but not limited to, our failure to successfully
commercialize our product candidates; costs and delays in the development
and/or FDA approval, or the failure to obtain such approval, of our product
candidates; uncertainties or differences in interpretation in clinical trial
results; our inability to maintain or enter into, and the risks resulting from
our dependence upon, collaboration or contractual arrangements necessary for
the development, manufacture, commercialization, marketing, sales and
distribution of any products; competitive factors; our inability to protect
our patents or proprietary rights and obtain necessary rights to third party
patents and intellectual property to operate our business; our inability to
operate our business without infringing the patents and proprietary rights of
others; general economic conditions; the failure of any products to gain
market acceptance; our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry practice;
and one-time events. We do not intend to update any of these factors or to
publicly announce the results of any revisions to these forward-looking
statements.
Vidaza^® is a registered trademark of Celgene Corporation. Dacogen^® is a
registered trademark used by Eisai Inc. under license from Astex
Pharmaceuticals, Inc. Zolinza^® is a registered trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc.
SOURCE MEI Pharma, Inc.
Website: http://www.meipharma.com
Contact: Pete De Spain, +1-858-792-3729, pdespain@meipharma.com